Safety and tolerability of RV568 in patients with COPD

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of treatment with repeat doses of inhaled RV568 in patients with COPD.

• IRAS ID

  88586

• Contact name

  Leonard Siew

• Sponsor organisation

  RespiVert Ltd

• Eudract number

  2011-004031-31

• Research summary

  The study medicine is a new drug that has potential value in the treatment of Chronic Obstructive Lung Disease (COPD). Chronic Obstructive Pulmonary Disease (COPD) or smoking related lung disease refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become inflamed and the small airsacs of the lungs become damaged. The disease is predominantly caused by long term smoking and there is a limitation of the flow of air to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of airflow is poorly reversible and usually gets progressively worse over time. Inflammation of the airways is a key component of smoking related lung disease. There is an urgent medical need for therapies that could slow disease progression by targeting the underlying mechanisms associated with the changes in the lungs in patients with smoking related lung disease including inflammation. The purpose of this study is to examine the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) multiple inhaled doses of the study medication in patients with COPD. Two dose strengths will be tested in this study. 30 patients with COPD will be enrolled into the study. The study is being conducted in 2 centres, London and Manchester. The total duration for participation in this study is approximately 6-8 weeks. It consists of 1 or 2 outpatient-screening visit(s) followed by 1 treatment period and 2 outpatient follow-up visits. The treatment period will be 14 days in duration. At the London site the treatment period will consist of a 16-day admission. At the Manchester site the treatment period will consists of two 2-day admissions, and daily outpatient visits to the Research Unit for 11 consecutive days.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/1397

• Date of REC Opinion

  15 Nov 2011

• REC opinion

  Further Information Favourable Opinion